The present invention provides methods and compositions for the oral administration of lactobacilli or other probiotic organisms such as Bifidobacterium, for reduction of the risk of urogenital infection and concomitant restoration and/or maintenance of the desired urogenital flora.
Urogenital infections, including urinary tract infections (UTI), bacterial vaginosis (BV) and yeast vaginitis, afflict an estimated one billion women in the world annually. While antimicrobial agents are effective at providing clinical remediation, the incidence of infections by multi-drug resistant Gram positive cocci appears to be rising and there is great concern that methicillin resistant Staphylococcus aureus (MRSA) and vancomycin resistant enterococci (VRE) may thwart even the most potent antimicrobial agents.
The mode of action of urogenital pathogens is now better understood and involves formation of biofilms in the intestine. Intestinal biofilms then become a reservoir for urogenital pathogens which invade the urogenital tract, where more biofilms are formed. Urogenital tract biofilms then become the reservoir for infection of the vagina (for example by yeast and bacteria causing vaginosis) and the urinary tract (for example by organisms causing urinary tract infections).
Previous studies have shown that specially selected probiotic lactobacilli, provided in a pessary inserted into the vagina, can colonize (Reid, et al. 1994) and compete against colonization of enterococci and other uropathogens (Bruce and Reid, 1998). The art also describes the use of Lactobacillus to prevent and treat urinary and urogenital infections.
The present invention demonstrates specially selected lactobacilli with antagonistic properties against urogenital pathogens, can colonize the vagina and provide protection against infection after oral intake. The present invention, for the first time, establishes that oral intake of Lactobacillus can successfully deliver probiotic therapy to women in need thereof.
The present invention provides methods and compositions for the treatment and inhibition of urogenital infection caused by pathogenic organisms. Oral administration of Lactobacillus, other probiotic compounds in a pharmaceutically acceptable carrier, such as milk or portions thereof, including yogurt, provide a safe and effective means for colonizing the intestine, urinary tract and vagina and treating, inhibiting or reducing the occurrence of urogenital infections.
In the practice of the compositions and methods of the present invention, the Lactobacillus may be administered as viable whole cells. The Lactobacillus species may be aerobically grown or microaerophillically grown and selected from L. rhamnosus, L. acidophilus, L. crispatus, L. fermentum, L. plantarum, L. casei, L. paracasei, L. jensenil, L. gasseri, L. cellobiosis, L. brevis, L. delbrueckii, L. rogosae and L. bifidum. 
The present invention provides a method for preventing, treating or reducing the occurrence of urogenital infections in a mammal in need of such treatment by oral administration of Lactobacillus.
In one embodiment of the present invention a method is provided for establishing a healthy gastrointestinal and urogenital flora in females throughout life comprising orally administering a therapeutically effective amount of at least one probiotic organism and a pharmaceutically acceptable carrier. In a further embodiment of the method a therapeutically effective amount of a second probiotic organism is administered. Lactobacillus is the preferred probiotic organism. Bifidobacteria is the preferred second probiotic organism. The Bifidobacterium is preferably selected from the group consisting of B. bifidum, B. breve, B. adolescentis, or B. longum. 
In another embodiment, the present invention describes a method for improving the intestinal, urogenital and vaginal microenvironment by oral administration of Lactobacillus.
In still another embodiment, the present invention provides a method for inhibiting, treating or reducing the occurrence of urogenital infections in a mammal in need of such treatment by oral administration of Lactobacillus and other probiotic organisms. In a preferred embodiment, the probiotic organism is Bifidobacterium.
In still yet another embodiment, the present invention describes a method for inhibiting urogenital pathogen colonization of the gastrointestinal and urogenital tract in mammals. In a preferred embodiment, the mammals are humans. In another embodiment, the urogenital pathogens are Escherichia coli, Klebsiella spp., Pseudomonas spp., Proteus spp., Providencia spp., Staphylococcus spp. , Streptococcus spp., Bacteroides spp., Mobiluncus spp. Trichomonas spp. Fusobacterium spp., Enterococcus spp., Gardnerella spp. and/or yeast.
In a further embodiment, the present invention describes a method for maintaining healthy urogenital flora by oral intake of Lactobacillus.
In a most preferred embodiment, the Lactobacillus species are L. rhamnosus GR-1 (ATCC 55826), L. fermentum RC-14 (ATCC 55845) and L. fermentum B-54 (ATCC 55884).
In another embodiment, the present invention provides a method for preventing or reducing the biofilm load of urogenital pathogens in the intestine, vagina, perineum and bladder in a mammal in need of such treatment by oral administration of Lactobacillus, anti-urogenital pathogen probiotics together with a suitable carrier.
In still another embodiment, the present invention provides a probe for the detection of lactobacilli in a biological sample.
In a preferred embodiment, the suitable carrier is milk or portions thereof, including yogurt and other such foods, including, but not limited to, milk shakes and powdered milk products; non-milk products and non-lactose containing products, including calcium carbonate.